Registration Dossier
Registration Dossier
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EC number: 476-900-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The irritating potential of the test substance registered was tested in New Zealand White rabbits in an OECD 404 study: Result not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin irritation potential of the test substance registered was investigated according to OECD 404. The test substance (0.5g) was applied topical by semi-occlusive conditions for 4 hours to 3 adult New Zealand White rabbits. The application resulted in mild signs of irritation. These effects were reversible and no longer evident 7 days after treatment. The score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal). The mean erythema/eschar score of the three animals was 0.67, 1.00 and 1.33, respectively and the mean oedema score was 0.00 for all three animals, respectively. Thus the test item did not induce significant or irreversible damage to the skin.
The eye irritation potential of the test substance registered was investigated according to OECD 405. The test substance (0.1g) was applied into the left eye of three young adult New Zealand White rabbits. The score was calculated across 3 scoring times (24, 48 and 72 hours after application). The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.33 for all three animals, respectively. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus the test item did not induce significant or irreversible damage to the rabbit eye.
Justification for classification or non-classification
Based on the result from an OECD 404 and an OECD 405 study the substance is not irritating to the rabbit skin or the rabbit eye. The substance registered has not to be classified.
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